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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Speculum, Vaginal, Nonmetal, Fiberoptic
510(k) Number K897100
Device Name CENTURION VAGINAL SPECULUM
Applicant
Tri-State Hospital Supply Corp.
301 Catrell Dr.
P.O. Box 170
Howell,  MI  48843
Applicant Contact GEORGE J PLUTA
Correspondent
Tri-State Hospital Supply Corp.
301 Catrell Dr.
P.O. Box 170
Howell,  MI  48843
Correspondent Contact GEORGE J PLUTA
Regulation Number884.4530
Classification Product Code
HIC  
Date Received12/21/1989
Decision Date 03/16/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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